Fampridina Accord

Package leaflet: Information for the patient

Fampridina Accord 10 mg prolonged-release tablets

fampridina
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Fampridina Accord is and what it is used for
2. What you need to know before taking Fampridina Accord
3. How to take Fampridina Accord
4. Possible side effects
5. How to store Fampridina Accord
6. Contents of the pack and other information

1. What Fampridina Accord is and what it is used for

Fampridina Accord contains the active substance fampridina, which belongs to a class of medicines known as potassium channel blockers. These medicines act by blocking the leakage of potassium that occurs in nerve cells damaged by multiple sclerosis (MS). This medicine is thought to work by facilitating the normal transmission of nerve signals, thereby improving the patient's walking ability.

Fampridina Accord is a medicine used to improve walking in adult patients (aged 18 years and older) with walking disability due to multiple sclerosis (MS). In multiple sclerosis, inflammation destroys the protective sheath surrounding the nerves, resulting in muscle weakness, muscle stiffness, and difficulty walking.

2. What you should know before taking Fampridina Accord

Do not take Fampridina Accord

• if you are allergic to fampridine or to any of the other ingredients of this medicine (listed in section 6)
• if you have had or have ever had an epileptic seizure (also known as a convulsive seizure or convulsion)
• if your doctor or nurse has told you that you have moderate or severe kidney problems
• if you are taking a medicine called cimetidine
• if you are taking other medicines containing fampridine. In this case, the risk of serious side effects may increase

If any of the above apply to you, inform your doctor and do not take
Fampridina Accord.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fampridina Accord:

• if you feel your heartbeat ( palpitations )
• if you are particularly susceptible to infections
• if you have any factors predisposing you to seizures or are taking any medicine affecting the risk of seizures ( epileptic seizure )
• if a doctor has told you that you have mild kidney problems.
• if you have a history of allergic reactions. You should use an aid for walking (e.g., a cane) as needed, because this medicine may cause dizziness or instability, thus increasing the risk of falls.

If any of the above apply to you, inform your doctor before taking
Fampridina Accord.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
Elderly
Before starting treatment and during therapy, your doctor may check your kidney function.
Other medicines and Fampridina Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Fampridina Accord if you are taking any other medicine containing
fampridine.
Medicines that affect the kidneys
Your doctor will proceed with particular caution if fampridine is taken together with medicines that may affect how the kidneys eliminate drugs, such as
carvedilol, propranolol, and metformin.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please seek advice from your doctor before taking Fampridina Accord.
Fampridina Accord is not recommended during pregnancy.
Your doctor will assess the benefit-risk balance of treatment with Fampridina Accord for you and the potential risks for the unborn child.
Do not breastfeed while being treated with this medicine.
Driving and using machines
Fampridina Accord may affect your ability to drive or operate machinery. The medicine may cause dizziness. Before driving or operating machinery, make sure you are not affected by such symptoms.

3. How to take Fampridina Accord

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Fampridina Accord is available only on prescription and must be used under the supervision of doctors experienced in the treatment of multiple sclerosis.
Your doctor will initially prescribe the medicine for a period of 2 to 4 weeks. Treatment will be re-evaluated after 2–4 weeks.
The recommended dose is
One tablet in the morning and one tablet in the evening (12 hours apart). Do not take more than two tablets per day. Leave 12 hours between one tablet and the next. Do not take the next tablet before 12 hours have passed since the previous one.
Fampridina Accord is a medicine for oral use.
Swallow the tablet whole with a glass of water. The tablet must not be broken, crushed, dissolved, sucked or chewed, as this could increase the risk of adverse effects.
This medicine must be taken without food, on an empty stomach.
If you take more Fampridina Accord than you should
If you take too many tablets, contact your doctor immediately.
When you go to the doctor, bring the Fampridina Accord packaging with you.
Symptoms of overdose may include sweating, mild trembling ( tremor ), dizziness, confusion, memory loss ( amnesia ) and seizures ( epileptic seizure ). Other adverse effects not listed may also occur.
If you forget to take Fampridina Accord
If you forget to take a tablet , do not take a double dose to make up for the missed tablet. You must always leave 12 hours between one tablet and the next.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience seizures , stop taking Fampridina Accord and contact your doctor immediately.
If you develop one or more of the following allergic symptoms ( hypersensitivity ): swelling of the face, mouth,
lips, throat or tongue, skin redness or itching, chest tightness and breathing difficulties, stop taking Fampridina Accord and seek medical help immediately.

The side effects are listed below by frequency.

Very common side effects
May affect more than 1 in 10 people:

• urinary tract infection

Common side effects
May affect up to 1 in 10 people:

• feeling unsteady
• dizziness
• sensation of spinning ( vertigo )
• headache
• feeling tired or weak
• difficulty sleeping
• anxiety
• slight trembling ( tremor )
• sensation of numbness or tingling of the skin
• sore throat
• common cold ( nasopharyngitis )
• influenza
• viral infection
• breathing difficulties (shortness of breath)
• feeling unwell (nausea)
• vomiting
• constipation
• stomach discomfort
• back pain
• awareness of your heartbeat (palpitations)

Uncommon side effects
May affect up to 1 in 100 people:

• seizures ( epileptic seizure )
• allergic reaction ( hypersensitivity )
• severe allergy ( anaphylactic reaction )
• swelling of the face, lips, mouth or tongue ( angioedema )
• onset or worsening of facial neuropathic pain ( trigeminal neuralgia )
• increased heart rate (tachycardia)
• dizziness or loss of consciousness ( hypotension )
• skin rash/itchy rash ( urticaria )
• chest discomfort

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system mentioned in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fampridina Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fampridina Accord contains

• The active substance is fampridine.
• Each prolonged-release tablet contains 10 mg of fampridine.
• Other components are:
• tablet core: hypromellose (E464), colloidal anhydrous silica (E551), microcrystalline cellulose (E460), magnesium stearate (E572);
• film coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521)

Description of the appearance of Fampridina Accord and package contents
White to off-white, oval-shaped, biconvex film-coated tablets of approximately 13.1 x 8.1 mm, with beveled edges and "FH6" engraved on one side, smooth on the other side.
Fampridina Accord 10 mg prolonged-release tablets are packaged in perforated unit-dose blisters containing 28 x 1, 49 x 1, 56 x 1 or 196 x 1 tablets (composed of 4 cartons, each containing 49 × 1 tablets).
Not all pack sizes or presentations may be marketed.

Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6a Planta,
Barcelona, 08039
Spain

Manufacturer
Accord Healthcare Polska Sp.z.o.o.
Ul. Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA3000, Malta
Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona, Spain
Accord Healthcare single member S.A. 64th Km
National Road Athens, Lamia,
Schimatari, 32009,
Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
BE / BG / CZ / DK / DE / EE / IE / ES / FR / HR / IT / CY / LV / LT / LU / HU / MT / NL / AT /
PL / PT / RO / SI / SK / FI / SE
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica A.E.
Tel: +30 210 7488 821

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .